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The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System (Closer)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02136004
First Posted: May 12, 2014
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rex Medical
  Purpose
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.

Condition Intervention
Surgical Wound Device: Closer VSS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Closer Trial: A Multi-center, Prospective, Single Arm Trial to Evaluate the Safety and Efficacy of the Rex Medical Closer Vascular Sealing System (VSS) for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures

Further study details as provided by Rex Medical:

Primary Outcome Measures:
  • Time to Hemostasis [ Time Frame: procedural, usually within 15 minutes of enrollment ]
    Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis

  • Rate of Combined Major Access Site Closure-related Complications [ Time Frame: Through 30 days +/- 7 days ]
    Primary safety endpoint - rate of combined major access site closure-related complications


Secondary Outcome Measures:
  • Time to Ambulation [ Time Frame: prior to hospital discharge, usually within 24 hours ]
    Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site

  • Time to Discharge Eligibility [ Time Frame: prior to hospital discharge, usually within 24 hours ]
    Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)

  • Time to Hospital Discharge [ Time Frame: through hospital discharge, usually within 24 hours ]
    Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward

  • Device Success [ Time Frame: procedural, usually within 15 minutes of enrollment ]
    Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression

  • Rate of Combined Minor Access Site Closure-related Complications [ Time Frame: through 30 +/- 7 days ]
    Secondary safety endpoint - rate of combined minor access site closure-related complications

  • Procedure Success [ Time Frame: through 30 days +/- 7 days ]
    Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days


Enrollment: 220
Study Start Date: May 2014
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closer VSS
Rex Medical Closer Vascular Sealing System to close femoral arteriotomy
Device: Closer VSS
At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Other Name: Rex Medical Closer TM Vascular Sealing System (VSS)

Detailed Description:
The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Pre-Op Inclusion Criteria:

1 - Acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5, 6, or 7 Fr introducer sheath.

Exclusion Criteria:

Pre-Operative Exclusion Criteria:

  1. - Significant bleeding diatheses or coagulopathy
  2. - Planned endovascular or surgical procedures within next 30 days
  3. - Planned ipsilateral femoral arteriotomy within next 90 days
  4. - Arteriotomy in ipsilateral groin within the past 30 days with any residual hematoma, significant bruising or vascular complication
  5. - Previous vessel closure device used in ipsilateral groin within the past 90 days
  6. - Previous vascular surgery or repair in the vicinity of the target access site
  7. - Severe peripheral vascular disease in the ipsilateral limb requiring surgical or endovascular treatment within the pervious 30 days or next 30 days
  8. - Existing nerve damage in ipsilateral limb
  9. - Extreme morbid obesity (BMI > 4 kg/m2)

    Intra-operative Exclusion Criteria:

  10. - Use of a procedural sheath that is < 5 Fr or > 7 Fr
  11. - Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure
  12. - Placement of an ipsilateral venous sheath for procedure
  13. - Procedural sheath placement either through the superficial femoral artery and into the profunda femoris artery, or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery
  14. - In subjects receiving unfractionated heparin, an ACT > 350 seconds, or > 250 seconds in the presence of a GP IIb/IIIa inhibitor
  15. - Procedures or existing medical conditions that may extend index hospitalization beyond 24 hours post-procedure
  16. - Systemic hypertension (SBP > 180 mmHg) or hypotension (SBP < 90 mmHg) just prior to enrollment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136004


Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
Colorado Neurological Institute
Englewood, Colorado, United States, 80113
United States, District of Columbia
Washington Hospital Center
Washington, D.C., District of Columbia, United States, 20010
United States, Louisiana
Lafayette General Medical Center/Cardiovascular Institute of the South
Lafayette, Louisiana, United States, 70503
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10065
United States, Ohio
North Ohio Research
Elyria, Ohio, United States, 44035
United States, Oklahoma
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Geisinger Health Center
Danville, Pennsylvania, United States, 17822
Geisinger Health Center
Wilkes-Barre, Pennsylvania, United States, 18711
Pinnacle Health
Wormleysburg, Pennsylvania, United States, 17043
United States, Texas
Heart Hospital of Austin
Austin, Texas, United States, 78756
Sponsors and Collaborators
Rex Medical
Investigators
Principal Investigator: Shing-Chiu Wong, MD New York Presbyterian Hospital
  More Information

Responsible Party: Rex Medical
ClinicalTrials.gov Identifier: NCT02136004     History of Changes
Other Study ID Numbers: REX-US-2027-001
First Submitted: May 7, 2014
First Posted: May 12, 2014
Results First Submitted: November 1, 2016
Results First Posted: December 29, 2016
Last Update Posted: October 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After multi-center manuscript is published.

Keywords provided by Rex Medical:
arteriotomy
vessel closure
femoral access site

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries